Trial Outcomes & Findings for Positive Psychology for Chronic Pain Self-management (NCT NCT04321239)
NCT ID: NCT04321239
Last Updated: 2021-11-01
Results Overview
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2021-11-01
Participant Flow
Participant milestones
| Measure |
Intervention Group
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
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|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
age data not available for one participant
Baseline characteristics by cohort
| Measure |
Intervention Group
n=25 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=26 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 6.7 • n=25 Participants • age data not available for one participant
|
71.9 years
STANDARD_DEVIATION 7.6 • n=25 Participants • age data not available for one participant
|
71.8 years
STANDARD_DEVIATION 7.2 • n=50 Participants • age data not available for one participant
|
|
Sex: Female, Male
Female
|
23 Participants
n=25 Participants
|
23 Participants
n=26 Participants
|
46 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
5 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
25 Participants
n=26 Participants
|
50 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=25 Participants
|
24 Participants
n=26 Participants
|
47 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
26 participants
n=26 Participants
|
51 participants
n=51 Participants
|
|
Pain interference (PROMIS 6-item scale)
|
59.8 T-score
STANDARD_DEVIATION 6.6 • n=23 Participants • Two participants had missing data on this measure.
|
59.1 T-score
STANDARD_DEVIATION 7.9 • n=26 Participants • Two participants had missing data on this measure.
|
59.4 T-score
STANDARD_DEVIATION 7.3 • n=49 Participants • Two participants had missing data on this measure.
|
|
Physical functioning (PROMIS 4-item scale)
|
41.1 T-score
STANDARD_DEVIATION 7.0 • n=25 Participants
|
40.8 T-score
STANDARD_DEVIATION 6.4 • n=26 Participants
|
40.9 T-score
STANDARD_DEVIATION 6.7 • n=51 Participants
|
|
Social participation (PROMIS 4-item scale)
|
49.4 T-score
STANDARD_DEVIATION 9.4 • n=23 Participants • Missing data (missing items) on this measure for a total of 4 participants.
|
48.2 T-score
STANDARD_DEVIATION 8.9 • n=24 Participants • Missing data (missing items) on this measure for a total of 4 participants.
|
48.8 T-score
STANDARD_DEVIATION 9.1 • n=47 Participants • Missing data (missing items) on this measure for a total of 4 participants.
|
|
Resilience (Connor-Davidson 10-item scale)
|
3.1 units on a scale
STANDARD_DEVIATION 0.56 • n=25 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 0.49 • n=26 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.52 • n=51 Participants
|
|
Pain Self-Efficacy
|
4.7 units on a scale
STANDARD_DEVIATION 1.3 • n=25 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 1.3 • n=26 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 1.3 • n=51 Participants
|
|
Pain intensity (0 to 10)
|
6.3 units on a scale
STANDARD_DEVIATION 1.9 • n=25 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.5 • n=26 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=51 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=23 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
|
|---|---|---|
|
Change in Pain Interference
|
-3.82 T-score
Standard Deviation 5.2
|
.32 T-score
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who had both baseline and follow-up data on this measure.
The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.
Outcome measures
| Measure |
Intervention Group
n=22 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=24 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
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|---|---|---|
|
Change in Self-reported Physical Functioning
|
43.7 T-score
Standard Deviation 7.7
|
40.9 T-score
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants with baseline and follow-up data on this measure.
How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=24 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
|
|---|---|---|
|
Participant Global Impression of Change--Pain
|
6.1 units on a scale
Standard Deviation .97
|
4.4 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, positive change value is a better outcome.
The Pain Self-Efficacy Questionnaire, a 10-item scale (Nicholas 1989) rating confidence at doing specific things (e.g., chores, accomplishing goals, becoming more active) despite pain; each item scored from 0=not at all confident to 6=completely confident.
Outcome measures
| Measure |
Intervention Group
n=22 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=24 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
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|---|---|---|
|
Change in Pain Self-efficacy
|
.36 units on a scale
Standard Deviation .91
|
-.16 units on a scale
Standard Deviation .71
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value (or smaller positive change) is a better outcome.
Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.
Outcome measures
| Measure |
Intervention Group
n=18 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=23 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
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|---|---|---|
|
Change in Social Participation
|
.11 T-score
Standard Deviation 4.4
|
.17 T-score
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, positive change value is a better outcome.
10-item version of the Connor-Davidson resilience scale rating the degree (0=not true at all to 4=true nearly all the time) respondent can cope/be resilient in various situations. Higher score means more resilience.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=24 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
|
|---|---|---|
|
Change in Resilience
|
.10 units on a scale
Standard Deviation .38
|
-.02 units on a scale
Standard Deviation .44
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants with baseline and follow-up data on this measure.
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=24 Participants
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
|
|---|---|---|
|
Participant Global Impression of Change - Functioning
|
6.4 units on a scale
Standard Deviation .74
|
4.6 units on a scale
Standard Deviation 1.4
|
Adverse Events
Intervention Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group
n=25 participants at risk
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
|
Usual Care Control Group
n=26 participants at risk
After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
hospitalization
|
4.0%
1/25 • Two months
|
0.00%
0/26 • Two months
|
|
Cardiac disorders
hospitalization
|
4.0%
1/25 • Two months
|
0.00%
0/26 • Two months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place